Transanal Irrigation for Low Anterior Resection Syndrome.

Low Anterior Resection Syndrome Clinical Trial

— HiLoV_TAI  

Official title:

High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245331
• Other study ID #: PR297/21
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: October 2023
• Source: Hospital Universitari de Bellvitge
• Contact: Loris Trenti, PhD
• Phone: +34 932607500
• Email: loris.trenti[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).

Description:

Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.

• Major LARS (score 30-42).

• At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.

• Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2.

• Age= 18 years

Exclusion Criteria:

• Side to end mechanical anastomosis or J-pouch colorectal anastomosis

• Partial or total intersphincteric resection.

• Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.

• Persona history of other colorectal, proctologic or pelvis surgery or disease.

• Personal history of bariatric surgery.

• Functioning sacral neurostimulator carriers.

• Previous use of transanal irrigation systems for LARS treatment

• Presence of an ostomy.

• Local or distant rectal cancer recurrence and/or any other active neoplastic disease.

• Altered cognitive status.

• Pregnancy and age < 18 years

• Any other diseases that may alter results of the study.

• Refusal to sign the informed consent.

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

Intervention

Device:
• Peristeen® Transanal irrigation system with the conic catheter
The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.
• Standard reusable enema
The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.

Locations

Country	Name	City	State
Spain	Bellvitge University Hospital	Barcelona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Asociación Española de Cirugía, Asociacion Española de Coloproctologia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LARS score	LARS score changes with treatments.; No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.	day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary	Daily bowel movements number (total, day, and night)	Defecation habits change with treatments	recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)
Secondary	Short Form 36 quality of live questionnaire (SF-36)	Quality of life changes with treatments.; Values between 0-100 (higher score means better outcome).	day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary	Vaizey score	Fecal incontinence symptoms change with treatments.; Values between 0-24 (higher score means worse outcome).	day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary	Satisfaction grade (VAS: 0-10).	Patients' satisfaction grade related with treatments	day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary	Preferred treatments	What treatment is preferred by the patients after having tried both	day 135
Secondary	Adverse effects related to both treatments.	Adverse effects and complication directly related with one of the two treatments.	day 1 to 135.